CARCINOMA OF THE ORAL CAVITY AND OROPHARYNX
Conditions
Brief summary
Superiority of electrochemotherapy treatment with bleomycin in terms of objective response compared to treatment with cetuximab + platinum-based therapy + 5-fluorouracil.
Detailed description
Overall survival, Assessment of disease-free progression time between the two groups, Evaluation of the duration of the response intended as the time from the first complete or partial response documentation to the first occurrence of disease or death progression, Assessment of disease control,intended as complete response, partial response and stable disease, between the two groups, Quality of life assessment (EORTC QLQ-C30, EORTC QLQ-H & N35, EQ-5D-5L) with particular attention to the effect on pain and bleeding between the two groups
Interventions
DRUGFluorouracile Teva 250 mg/5 ml soluzione per infusione
DRUGCETUXIMAB
DRUGPEMBROLIZUMAB
DRUGCisplatino Teva Italia 0
DRUG5 mg/ml concentrato per soluzione per infusione
Sponsors
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Superiority of electrochemotherapy treatment with bleomycin in terms of objective response compared to treatment with cetuximab + platinum-based therapy + 5-fluorouracil. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Assessment of disease-free progression time between the two groups, Evaluation of the duration of the response intended as the time from the first complete or partial response documentation to the first occurrence of disease or death progression, Assessment of disease control,intended as complete response, partial response and stable disease, between the two groups, Quality of life assessment (EORTC QLQ-C30, EORTC QLQ-H & N35, EQ-5D-5L) with particular attention to the effect on pain and bleeding between the two groups | — |
Countries
Italy
Outcome results
None listed